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    2. Safety and tolerability of Jorveza® (budesonide) orally disintegrating tablets
Safety and tolerability of Jorveza® (budesonide) orally disintegrating tablets
1. How safe and well tolerated is Jorveza®?

Budesonide has low systemic absorption, including when administered as Jorveza®. As such, the risk of systemic adverse events (AE) is low vs. the systemically acting prednisolone.1 Consistent with this, no significant changes were observed in morning serum cortisol levels from baseline to the end of treatment in the 48-week maintenance study. The main AE reported in this 48 week study and in the preceding 12 week induction study was a localised fungal infection, in the mouth, throat, or oesophagus, all of which were all of mild or moderate intensity and which did not interfere with their daily activities.2–4 In the 48 week study, suspected symptomatic fungal infections were reported in 11.8% and 16.2% of patients receiving the 1 mg BID and 0.5 mg BID regimens, respectively.4 Of these, histologic confirmation occurred in 2.9% and 7.4% of patients, respectively, demonstrating the lack of a dose-dependent effect. All of these patients were successfully treated with an oral anti-fungal agent, while maintaining their allocated study treatment.2,3

A summary of adverse effects reported during the induction and maintenance of clinicohistologic remission studies for Jorveza® is available in the Product Information.

 

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING.
COPIES OF THE PRODUCT INFORMATION FOR JORVEZA® CAN BE REQUESTED BY CALLING DR FALK PHARMA AUSTRALIA PTY LTD ON 1800 DRFALK (1800 373 233), OR AT THERAPEUTIC GOODS ADMINISTRATION.

PBS Information: Authority required for the treatment of EoE.
Refer to the PBS Schedule for full authority information.

 

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2. References
  • Lucendo AJ, Molina-Infante J, Arias Á, von Arnim U, Bredenoord AJ, Bussmann C et al. Guidelines on eosinophilic oesophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J 2017; 5(3):335–58.
  • Lucendo A, Miehlke S, Vieth M, Schlag C, Biedermann L, Santander C, et al. 951a – Budesonide orodispersible tablets are highly effective to maintain clinico-histological remission in adult patients with eosinophilic oesophagitis: Results from the 48-weeks, double-blind, placebo-controlled, pivotal Eos-2 trial. Gastroenterology. 2019;156(6):S–1509 Abstr. 951a.
  • Straumann A, Lucendo A, Miehlke S, Vieth M, Schlag C, Biedermann L, et al. Budesonide orodispersible tablets are superior to maintain combined clinical and histological remission in adult patients with eosinophilic oesophagitis: results from the 48-weeks, double-blind, placebo-controlled pivotal EOS-2-trial. UEG Journal. 2019;7 Suppl I:53–4 OP89.
  • Lucendo AJ, Miehlke S, Schlag C, von Arnim U, Molina-Infante J et al. Efficacy of budesonide orodispersible tablets as induction therapy for eosinophilic oesophagitis in a randomized placebo-controlled trial. Gastroenterology 2019; 157:74–86.
  • Jorveza® Product Information.

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